TIDMHCM
RNS Number : 8102Z
Hutchison China Meditech Limited
05 September 2018
Chi-Med Announces the Approval of Fruquintinib Capsules for
Previously Treated Colorectal Cancer in China
- Fruquintinib capsules provide a new oral treatment option for
patients with metastatic colorectal cancer and will be marketed as
Elunate(R) -
- Elunate(R) data published in JAMA demonstrated increased
overall survival versus placebo -
- First ever approval of an innovative medicine by Chi-Med -
- The first China-discovered and developed treatment for CRC
approved in China -
London: Wednesday, September 5, 2018: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that
fruquintinib capsules have been granted approval for drug
registration by the National Medical Products Administration of
China ("NMPA", formerly the China Food and Drug Administration) for
the treatment of metastatic colorectal cancer ("CRC") patients, who
have failed at least two prior systemic antineoplastic therapies
including fluoropyrimidine, oxaliplatin and irinotecan, with or
without prior use of anti-vascular endothelial growth factor
("VEGF") or anti-epidermal growth factor receptor ("EGFR")
therapies. Fruquintinib is a highly selective and potent small
molecule oral inhibitor of vascular endothelial growth factor
receptors ("VEGFR") 1, 2 and 3 designed to be a global
best-in-class VEGFR inhibitor for many types of solid tumors.
Fruquintinib capsules are to be marketed in China under the brand
name Elunate(R) . The approval is based on results from the Phase
III FRESCO trial, which were presented at the American Society of
Clinical Oncology 2017 Meeting and published in the JAMA (Journal
of the American Medical Association) in 2018.
"Today's approval is a major achievement for Chi-Med," said
Simon To, Chairman of Chi-Med. "Elunate(R) is the first home-grown,
China-discovered and developed drug we are aware of in an oncology
indication to be unconditionally approved through a randomized
clinical trial in China," he added, "This is the result of over a
dozen years of steadfast commitment by Chi-Med in research and
development in China's emerging biotech ecosystem."
"We are particularly grateful to the patients, their families,
investigators, nurses, caregivers and study team members who
participated in the clinical development of Elunate(R) and now look
forward to making this world-class new therapy available as quickly
as possible to patients with CRC in China."
In the FRESCO trial led by Dr. Jin Li and Dr. Shukui Qin,
Elunate(R) was shown to provide a statistically significant and
clinically meaningful improvement in overall survival ("OS") versus
placebo, with median OS of 9.3 (95% CI 8.2, 10.5) vs. 6.6 (95% CI
5.9, 8.1) months, respectively (HR=0.65, 95% CI 0.51-0.83;
p<0.001), and a manageable safety profile. In addition to the
significant efficacy, fruquintinib's good kinase selectivity has
been shown to limit off-target toxicity and deliver what Chi-Med
assesses to be best-in-class tolerability. This allows it to be
evaluated in combination with other agents such as chemotherapies,
targeted therapies and immunotherapies, thereby maximizing the
number of potential patients who may benefit from this novel cancer
treatment.
CRC is the second most common cancer type in China,([1]) with
about 380,000 new cases per year.([2]) There were approximately 1.5
million new CRC cases globally in 2015 which are expected to
increase to approximately 1.7 million new cases per year by 2020,
according to Frost & Sullivan.
The market launch of Elunate(R) in China will be through
collaboration with our partner Eli Lilly & Company ("Lilly").
Dr. Wang Li, Senior Vice President, Head of Lilly China Drug
Development & Medical Affairs Center, said, "The approval is a
testament to the overall clinical profile of Elunate(R) and is an
important step forward for our collaboration with Chi-Med." This
approval also triggers an approximately US$13.6 million milestone
payment to Chi-Med from Lilly.
About Elunate(R)
Elunate(R) is the brand name of fruquintinib capsules.
Fruquintinib (HMPL-013) is a small molecule, selective and highly
potent inhibitor of VEGFR 1, 2 and 3. VEGFR inhibitors play a
pivotal role in tumor-related angiogenesis, cutting off the blood
supply that a tumor needs to grow rapidly. The global market for
anti-angiogenesis therapies was estimated at approximately US$18
billion in 2017, with both monoclonal antibodies and small
molecules approved in around 30 tumor types. During the discovery
research process, which began at Chi-Med in 2007, fruquintinib was
successfully designed to be differentiated by improving kinase
selectivity in comparison to other approved small molecule tyrosine
kinase inhibitors (TKIs), to minimize off-target toxicities,
improve tolerability and provide more consistent target coverage,
resulting in better clinical efficacy. The superior tolerability,
along with fruquintinib's low potential for drug-drug interaction
based on preclinical assessment, suggests that it may be highly
suitable for innovative combinations with other anti-cancer
therapies.
In October 2013, Chi-Med entered into a licensing,
co-development and commercialization agreement in China with Lilly
for fruquintinib. Under the terms of the agreement, the costs of
development of fruquintinib, carried out by Chi-Med, are shared;
Chi-Med has received upfront payments and development and
regulatory approval milestone payments; and upon commercialization
in China, Chi-Med would receive royalties. Chi-Med and Lilly agreed
to develop fruquintinib in three initial solid tumor indications,
CRC, non-small cell lung cancer ("NSCLC") and gastric cancer.
The most common adverse reactions included hypertension,
hand-foot syndrome and proteinuria. Clinically effective management
of these adverse effects is feasible. For important safety
information about Elunate(R) , please see www.chi-med.com.
About Fruquintinib Development in CRC in China
Clinical development of fruquintinib began in 2011 with an
initial Phase I trial in 40 solid tumor patients, followed by a
Phase Ib study in 62 CRC patients, and a Phase II clinical trial in
71 CRC patients. Chi-Med began enrollment in December 2014 of the
FRESCO study, a Phase III pivotal registration trial of
fruquintinib in 416 patients in China, and subsequently reported
positive top-line results in March 2017.
In October 2016, fruquintinib was the first novel drug to be
granted Market Authorization Holder ("MAH") designation under the
Shanghai FDA, a new system designed to improve speed and efficiency
of novel drug development in China. The New Drug Application
("NDA") for fruquintinib in CRC, that was submitted in June 2017
and awarded priority review status in September 2017, was supported
by data from the successful FRESCO study. FRESCO was highlighted in
an oral presentation at the ASCO Annual Meeting held on June 5,
2017, and then the full results were published in the JAMA on June
26, 2018. Additional details about the FRESCO study can be found at
clinicaltrials.gov, using identifier NCT02314819.
Fruquintinib is only approved for use in mainland China with the
approved dose in CRC being 5mg orally once per day, on a
three-weeks-on / one-week-off cycle and it will be made available
in the market in both 1mg and 5mg capsule packages.
About Other Fruquintinib Development Programs
Lung cancer in China: FALUCA is an ongoing randomized,
double-blind, placebo-controlled, multi-center, Phase III
registration study of fruquintinib treating patients with advanced
non-squamous NSCLC, who have progressed after two lines of systemic
chemotherapy. The trial completed enrollment of 527 patients in
February 2018 (clinicaltrials.gov identifier NCT02691299) and
top-line results are expected in late 2018. FALUCA was initiated
following a similar Phase II clinical trial in 91 third-line NSCLC
patients. Results were highlighted in an oral presentation at the
17(th) World Conference on Lung Cancer on December 6, 2016
(clinicaltrials.gov identifier NCT02590965).
Along with FALUCA, fruquintinib is concurrently being studied in
a Phase II study in combination with Iressa(R) (gefitinib) in
patients with untreated advanced or metastatic NSCLC
(clinicaltrials.gov identifier NCT02976116). Preliminary results
were highlighted in an oral presentation at the 18(th) World
Conference on Lung Cancer on October 16, 2017.
Gastric cancer in China: In October 2017, Chi-Med initiated a
pivotal Phase III clinical trial of fruquintinib in combination
with Taxol(R) (paclitaxel), known as the FRUTIGA study, in
approximately 500 patients with advanced gastric or
gastroesophageal junction ("GEJ") adenocarcinoma who have
progressed after first-line standard chemotherapy
(clinicaltrials.gov identifier NCT03223376). An interim analysis on
FRUTIGA, to establish proof-of-concept ("POC"), is anticipated
during the first half of 2019 and if successful could trigger a POC
milestone from Lilly. The FRUTIGA study followed a Phase I/II
clinical trial in 34 patients with gastric cancer that demonstrated
that combination therapy of fruquintinib and Taxol(R) was generally
well-tolerated with promising tumor response (clinicaltrials.gov
identifier NCT02415023).
United States: In December 2017, Chi-Med initiated a
multi-center, open-label, Phase I clinical study to evaluate the
safety, tolerability and pharmacokinetics of fruquintinib in U.S.
patients with advanced solid tumors (clinicaltrials.gov identifier
NCT03251378).
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which
researches, develops, manufactures and sells pharmaceuticals and
healthcare products. Its Innovation Platform, Hutchison MediPharma
Limited, focuses on discovering and developing innovative
therapeutics in oncology and autoimmune diseases for the global
market. Its Commercial Platform manufactures, markets, and
distributes prescription drugs and consumer health products in
China.
Chi-Med is majority owned by the multinational conglomerate CK
Hutchison Holdings Limited (SEHK: 1). For more information, please
visit: www.chi-med.com.
Iressa(R) is a trademark of the AstraZeneca PLC group of
companies. Taxol(R) is a trademark of The Bristol-Myers Squibb
Company group of companies.
Forward-Looking Statements
This announcement contains forward-looking statements within the
meaning of the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements reflect Chi-Med's current expectations regarding future
events, including its expectations for the ability of Elunate(R)
(fruquintinib capsules) to gain commercial acceptance in China, the
potential market of Elunate(R) for patients with metastatic CRC who
have failed two prior treatments in China, the ability for Chi-Med
to quickly provide Elunate(R) to patients by year end, and the
clinical development of Elunate(R) in other indications.
Forward-looking statements involve risks and uncertainties. Such
risks and uncertainties include, among other things, assumptions
regarding Chi-Med's ability to commercialize Elunate(R) , that the
benefits obtained from Elunate(R) during clinical trials will be
the same for all patients who are prescribed Elunate(R) , that no
unidentified side effects will occur which could result in the NMPA
pulling Elunate(R) from the market and the sufficiency of funding
to support commercialization of Elunate(R) in metastatic CRC and
the development of Elunate(R) in other indications. In addition, as
certain studies rely on the use of Iressa(R) (gefitinib) or
Taxol(R) (paclitaxel) as combination therapeutics with Elunate(R) ,
such risks and uncertainties include assumptions regarding the
safety, efficacy, supply and continued regulatory approval of
Iressa(R) and Taxol(R) . Existing and prospective investors are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. For further
discussion of these and other risks, see Chi-Med's filings with the
U.S. Securities and Exchange Commission and on AIM. Chi-Med
undertakes no obligation to update or revise the information
contained in this announcement, whether as a result of new
information, future events or circumstances or otherwise.
Inside Information
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President,
Corporate Finance & Development +852 2121 8200
David Dible, Citigate Dewe Rogerson +44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout +1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
Media Enquiries
UK & Europe - Anthony Carlisle, Citigate Dewe Rogerson +44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China - Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Mainland China - Sam Shen, Edelman +86 1367 179 1029 (Mobile)
sam.shen@edelman.com
Nominated Advisor
Richard Gray / Andrew Potts, Panmure Gordon (UK) Limited +44 (20) 7886 2500
([1]) R. Zheng, H. Zeng et al, Cancer Lett. 2016 Jan
1;370(1):33-8. National estimates of cancer prevalence in China,
2011. doi:10.1016/j.canlet.2015.10.003. Epub 2015 Oct 13.
([2]) W. Chen, R. Zheng et al, CA Cancer J Clin. 2016
Mar-Apr;66(2):115-32. Cancer Statistics in China, 2015.
doi:10.3322/caac.21338. Epub 2016 Jan 25.
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END
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